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To study the efficacy of sintilimab combined with anlotinib for perioperative non-small cell lung cancer. To explore the clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease.
Patients with resectable non-small cell lung cancer (NSCLC) have a high postoperative recurrence rate. Perioperative treatment, which can improve the resection rate and clear the minimal residual disease, is the main mean of preventing recurrence, including preoperative neoadjuvant and postoperative adjuvant therapies. In recent years, immunotherapy can significantly improve the pathological remission rate and prolong the survival as a perioperative treatment. In addition to single-agent or combined chemotherapy, the exploration of immunotherapy with other therapeutic strategies is still lacking.
In 2018, we originally designed sintilimab combined with anlotinib in the first-line treatment of advanced NSCLC.
This clinical study plans to: â‘ apply the "de-chemotherapy" model to the perioperative phase of early NSCLC, â‘¡ explore sintilimab combined with anlotinib in preoperative neoadjuvant and postoperative adjuvant therapies, â‘¢ explore clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease (MRD), in order to improve the efficacy of perioperative NSCLC and prolong survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination therapy group | Experimental | Sintilimab combined with anlotinib |
|
| Single-agent therapy group | Experimental | Sintilimab monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sintilimab combined with anlotinib | Drug | Sintilimab (200mg/time, every 3 weeks) combined with anlotinib (12mg, once daily on day 1 to 14 per cycle) for 2 cycles (42 days). Radical surgery is performed within 4 - 6 weeks treatment. Sintilimab combined with anlotinib therapy repeats every 3 weeks until one year after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathologic response (MPR) | Residual tumor cells of the surgical specimens were ≤10% based on pathological evaluation. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete pathologic response (CPR) | Residual tumor cells of the surgical specimens were 0% based on pathological evaluation. | 2 months |
| Event free survival (EFS) | Time from randomization to any of the following: disease progression; new primary NSCLC; death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tianqing Chu | Contact | 13661775640 | tianqing_chu@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Tianqing Chu Chu | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | China |
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| sintilimab monotherapy | Drug | Sintilimab (200mg/time, every 3 weeks) combined with anlotinib (12mg, once daily on day 1 to 14 per cycle) for 2 cycles (42 days). Radical surgery is performed within 4 - 6 weeks treatment. Sintilimab monotherapy repeats every 3 weeks until one year after surgery. |
|
|
| 16 months |
| Overall survival (OS) | Radiographic assessments were performed when enrolled and every 8 weeks until disease progression after chemotherapy according to RECIST version 1.1. After PD, collect the survival information every 16 weeks until death or withdrawal of study consent. | 32 months |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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